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NCT04144790 · ClinicalTrials.gov registry record
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
A clinical trial, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Completed
- Registry status
- 12
- Enrollment target
NCT04144790 is a clinical trial that has completed, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 12 participants.
The verdict
NCT04144790 has completed, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
The goal of the present study is to provide novel data to evaluate brain iron concentration as a mediator of the association between iron supplementation treatment and improvement in symptoms of ADHD and RLS in children, including PLMS. Twelve participants between the ages of 10 and 15 years will be recruited via Kennedy Krieger Institute's Sleep Disorders Clinic. Eligible participants will be asked to complete, at baseline (pre-iron supplementation treatment) and again at follow-up (post-treatment): 1) a 7 Tesla MRI scan, 2) five consecutive nights of RestEaZe™ monitoring, 3) caregiver-reported (or patient-reported if over the age of 10 years) International Restless Leg Syndrome Scale (IRLSS), and 4) caregiver-reported ADHD Rating Scale-5. The treatment interval will be 3 months.
Interventions
- DIETARY_SUPPLEMENT ferrous sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2025-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04144790
The ClinicalTrials.gov registry entry for NCT04144790 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ferrous sulfate is the first listed.
NCT04144790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04144790 about?
NCT04144790 is a clinical study titled "Impact of Iron Supplementation Treatment on Brain Iron Concentrations". The goal of the present study is to provide novel data to evaluate brain iron concentration as a mediator of the association between iron supplementation treatment and improvement in symptoms of ADHD and RLS in children, including PLMS. Twelve participants between the ages of 10 and 15 years will be...
What is the current status of trial NCT04144790?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2022-09-15. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04144790?
The interventions under investigation include: ferrous sulfate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04144790?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
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